CTRI Number |
CTRI/2025/06/088664 [Registered on: 12/06/2025] Trial Registered Prospectively |
Last Modified On: |
11/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
A study to find out how common Vitamin D deficiency is among adults visiting a hospital in Kerala |
Scientific Title of Study
|
A clinico- epidemiologic cross-sectional study of Vitamin D Deficiency among adulthood patients visiting the laboratory of a tertiary Care Hospital in Kerala |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kasthuri Nair A |
Designation |
Director |
Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
Address |
Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram
Thiruvananthapuram KERALA 695572 India |
Phone |
8113851665 |
Fax |
|
Email |
dr.kasthurinair@pkhil.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Arun Pratap |
Designation |
Professor |
Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
Address |
Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram
Thiruvananthapuram KERALA 695572 India |
Phone |
9567256333 |
Fax |
|
Email |
dr.arunpratap@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Arun Pratap |
Designation |
Professor |
Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
Address |
Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram
Thiruvananthapuram KERALA 695572 India |
Phone |
9567256333 |
Fax |
|
Email |
dr.arunpratap@gmail.com |
|
Source of Monetary or Material Support
|
Neyyar Medicity, Kattakada, Trivandrum, Kerala, Pin -695572 |
|
Primary Sponsor
|
Name |
nil |
Address |
nil |
Type of Sponsor |
Other [Student funded project] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Kasthuri Nair A |
Neyyar Medicity |
Room NO 1
Department of General Medicine Thiruvananthapuram KERALA |
8113851665
dr.kasthurinair@pkhil.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Adults aged 18 to 50 years
2. Both male and female patients visiting the laboratory for vitamin D testing
3. Willing to participate and provide informed consent
4. Capable of understanding and answering the questionnaire
|
|
ExclusionCriteria |
Details |
1. Patients with known chronic diseases affecting vitamin D metabolism (e.g., chronic kidney disease, liver disorders, parathyroid dysfunction)
2. Pregnant or lactating women
3. Patients unwilling to participate or unable to provide informed consent
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Prevalence of Vitamin D deficiency among adult patients visiting the laboratory |
The assessment will be Prevalence of Vitamin D deficiency will be evaluated at Day 1, i.e., on the day of the participants visit to the laboratory |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Outcome 1: Association of Vitamin D deficiency with lifestyle, dietary habits, sunlight exposure, physical activity, & BMI
• Outcome 2: Knowledge & awareness level regarding vitamin D among the study population
|
The assessment will be conducted at Day 1, i.e., on the day of the participants visit to the laboratory using a structured, interviewer-administered questionnaire. |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
23/06/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Vitamin D deficiency is a globally
prevalent public health problem, with substantial implications for bone health
and metabolic functions. Despite abundant sunshine, India, including the
southern state of Kerala, reports high prevalence of vitamin D deficiency due
to factors like sedentary lifestyle, indoor confinement, dietary habits, and
cultural practices. This study aims to assess the prevalence of vitamin D
deficiency among adults (aged 18–50 years) attending the laboratory of a
tertiary care hospital in Kerala, specifically Neyyar Medicity.
This cross-sectional study will involve
60 adult participants who undergo serum 25-hydroxyvitamin D testing. Data
collection will be conducted through a structured and validated questionnaire
that captures socio-demographic data, sun exposure, dietary patterns, lifestyle
factors, and awareness about vitamin D. The primary objective is to estimate
the proportion of individuals with deficient vitamin D levels, while secondary
objectives include identifying contributing risk factors and gauging
participant knowledge about deficiency symptoms and consequences.
Findings from this study are expected
to guide awareness campaigns and preventive strategies in the community and
contribute to developing public health recommendations to tackle this silent
epidemic. Ethical approval has been obtained from the Institutional Ethics
Committee of Pankajakasthuri Ayurveda Medical College and PG Centre,
Trivandrum. |